CLSI EP07:2018(R2022)

This guideline is intended for manufacturers and medical laboratories, for two purposes: • Assist manufacturers and other developers of laboratory measurement procedures in characterizing the effects of potential interferents on measurement procedures results by providing information on:– Relevant interferents and concentrations to be tested– Likely effects of the interferent on the concentration of the measurand of interest (ie, no effect, positive effect, or negative effect) – Scientifically valid experimental designs– Appropriate data analysis and interpretation – Stating meaningful interference claims • Assist medical laboratories in investigating discrepant results that may be due to interferents by:– Defining a systematic investigation strategy– Specifying data collection and analysis procedures– Promoting greater cooperation between laboratory scientists and manufacturers so that new interferents are identified, disclosed, and ultimately eliminated Any measurement procedure, quantitative or qualitative, may be subject to interference.